Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000396527
Ethics application status
Approved
Date submitted
11/03/2015
Date registered
29/04/2015
Date last updated
15/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a proprietary spearmint extract improve cognitive function?
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Trial Investigating a Proprietary Spearmint Extract on cognitive function in healthy individuals.
Secondary ID [1] 286038 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 294013 0
Condition category
Condition code
Alternative and Complementary Medicine 294314 294314 0 0
Other alternative and complementary medicine
Mental Health 294994 294994 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised, double-blind, placebo-controlled, parallel intervention trial. A total of 128 individuals aged 50 to 70 years will take part in the study with an intervention period of 90 days.

Participants will be required to complete four testing sessions (day 0, day 7, day 30 and day 90), and one screening session. At each session participants will be required to complete a series of measures assessing cognitive function.


Following visit 1 participants will be randomly allocated to receive one of the two treatments (administered in capsules)

- Proprietary spearmint extract (900 mg/day)
- Matched placebo (of microcrystalline cellulose)

The study product (two capsules) will be administered orally (self-administered at home) daily for 90 days. Compliance will be assessed by capsule count at each study visit.
Intervention code [1] 291024 0
Behaviour
Intervention code [2] 291025 0
Treatment: Other
Comparator / control treatment
Matched placebo (microcrystalline cellulose)
Control group
Placebo

Outcomes
Primary outcome [1] 294118 0
Cognitive function as assessed by the COMPASS cognitive assessment battery. The assessment battery includes tasks that assess attention, working memory, episodic memory and executive function domains.
Timepoint [1] 294118 0
Day 1 (visit 1)
Day 30 (visit 3)
Day 90 (visit 4)
Secondary outcome [1] 312539 0
Measures of general health as assessed by the following questionnaires:

- Profile of Mood States (POMS)
- Leeds Sleep Evaluation Questionnaire (LSEQ)
- Everyday Memory Questionnaire (EMQ)
- Quality of Life Index (QLI)
Timepoint [1] 312539 0
Day 1 (Visit 1)
Day 7 (Visit 2)
Day 30 (Visit 3)
Day 90 (Visit 4)
Secondary outcome [2] 312645 0
Biomarkers of oxidative stress as assessed by serum analysis.
Timepoint [2] 312645 0
Screening Visit
Day 90 (Visit 4)

Eligibility
Key inclusion criteria
People who meet the following inclusion criteria will be included in the trial:

- Male or female, aged 50 to 70 years, inclusive.
- Willing and able to provide written informed consent.
- Understands and is willing and able to comply with all study procedures.
- Fluent in written and spoken English.
- Are in good general health as judged by the Investigator on the basis of medical history and biochemical assessment.
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who display any of the following will be excluded from the trial:

- Participant is unable to understand and/or perform required tests according to the practice test results.
- Participant has a history of repeated minor head injury (e.g., in boxing) or a single injury resulting in a period of unconsciousness for 1 h or more.
- Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
- Subject has an active infection or signs/symptoms of an infection at clinic visit. Clinic visits will be rescheduled to allow subject to be symptom-free of any type of systemic infection for at least 5 days.
- Subject has recently used antibiotics (within 5 days of any clinic visit).
- Currently participating in or has participated in any other study involving an investigational product in the last 4 weeks.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be stratified to the intervention or control group based on their age, gender, and smoking (current user of tobacco or non-user of tobacco (no tobacco use for 6 months or more).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator was used to perform permuted block randomization.

Randomization codes will be kept in a sealed envelope in a secure filing cabinet. While the study is a double blind trial, study investigators will know the location of, and have access to, the sealed randomisation code envelope. This is in the event of an emergency where the content of the treatment is needed to be known. In the event that the code break envelope is opened, the ethics committee and the Sponsor will be informed. Each participants unblinding is considered on a case-by-case basis following authorisation by the Safety Committee which includes the Research Nurse, Chairman of the Safety Committee (General Practitioner [GP]) and the Principal Investigator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Randomised, double-blind, placebo-controlled, parallel intervention trial.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/04/2015
Actual
29/04/2015
Date of last participant enrolment
Anticipated
Actual
25/08/2016
Date of last data collection
Anticipated
Actual
14/12/2016
Sample size
Target
128
Accrual to date
Final
129
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 290628 0
Commercial sector/Industry
Name [1] 290628 0
Kemin
Country [1] 290628 0
United States of America
Primary sponsor type
University
Name
Centre for Human Psychopharmacology, Swinburne University.
Address
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
Australia
Country
Australia
Secondary sponsor category [1] 289320 0
None
Name [1] 289320 0
Address [1] 289320 0
Country [1] 289320 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292262 0
Bellberry Limited
Ethics committee address [1] 292262 0
Ethics committee country [1] 292262 0
Australia
Date submitted for ethics approval [1] 292262 0
Approval date [1] 292262 0
05/03/2015
Ethics approval number [1] 292262 0
2015-01-005

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54354 0
Prof Andrew Scholey
Address 54354 0
Centre for Human Psychopharmacology
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
Country 54354 0
Australia
Phone 54354 0
+61392148932
Fax 54354 0
Email 54354 0
ascholey@swin.edu.au
Contact person for public queries
Name 54355 0
Andrew Scholey
Address 54355 0
Centre for Human Psychopharmacology
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
Country 54355 0
Australia
Phone 54355 0
+61392148932
Fax 54355 0
Email 54355 0
ascholey@swin.edu.au
Contact person for scientific queries
Name 54356 0
Andrew Scholey
Address 54356 0
Centre for Human Psychopharmacology
Mail H24
PO Box 218
Hawthorn, Victoria, 3122
Country 54356 0
Australia
Phone 54356 0
+61392148932
Fax 54356 0
Email 54356 0
ascholey@swin.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.